News Center
05-08 2020

Luye Pharma Submits IND Application for Denosumab Injection in the U.S.

Author:Luye Life Sciences

Luye Pharma Group is accelerating its biopharmaceutical pipeline globally. Shandong Boan Biological Technology Co. Ltd, the subsidiary of Luye Pharma Group, has recently submitted the investigational new drug (IND) application for its recombinant anti-RANKL fully human monoclonal antibody injection product (Denosumab Injection) to the U.S. Food and Drug Administration (FDA). It is the first overseas IND application regarding the company's biopharmaceutical product.

Biopharmaceuticals, especially antibody drugs, are capturing a growing share of the global pharmaceuticals market. As one of the key business areas for the company, biopharmaceuticals is also seen by Luye Pharma as a strategic area for achieving leapfrog growth in the next few years. As a result, the company is actively increasing its spending on the development of biopharmaceuticals and accelerating the launch of a range of products in its pipeline.

The recombinant anti-RANKL fully human monoclonal antibody injection (Denosumab Injection), for which the IND application has been submitted in the U.S., is code-named LY06006 and LY01011. Denosumab injection at dose of 60mg/ml (LY06006, a biosimilar of Prolia®) is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer and treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Denosumab injection at the dose of 120 mg/1.7ml (LY01011, a biosimilar of Xgeva®) is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.

The industry is generally optimistic about the market prospects of the two drugs. According to public financial reports, Prolia® (the reference drug for LY06006) achieved global sales of US$2.67 billion in 2019, growing 16.6% YoY. Prolia® has not yet been launched in China. Xgeva® (the reference drug for LY01011) achieved global sales of US$1.94 billion in 2019, growing 8.3% YoY. Xgeva® was launched in China in May 2019.

In addition to the IND application submitted in the U.S., Phase III clinical trial for LY06006 and Phase I clinical trial for LY01011 are currently under way in China, and the company is ahead of competitors in R&D in China.

A senior spokesperson of Luye Pharma Group said: "Through our efforts, we hope to bring more high-quality biopharmaceutical products to patients, to provide for the huge unmet medical needs in China and around the world."

In terms of the company's biopharmaceutical pipeline, Luye Pharma has a wide range of antibody drugs at different stages of development. Among these, the Marketing Authorization Application for LY01008 (a biosimilar of Avastin®) has been submitted and accepted in China. Other products under development include LY09004 (a biosimilar of Eylea®), LY01012 (a biosimilar of Zaltrap®), LY01015 (a biosimilar of Opdivo®), and LY05008 (a biosimilar of Trulicity®) in addition to more than ten other innovative biopharmaceutical products under development. Luye Pharma has also developed multiple next-generation innovative antibody products in immuno-oncology by utilizing its own development platforms—such as fully human antibody transgenic mice—and by collaborating with multiple leading overseas biotech companies. This has allowed the company to keep expanding its presence in the field of biopharmaceuticals.

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